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Siemens Healthineers’ COVID-19 assay given approval for use in Europe

Editor's Note European regulators have approved Siemens Healthineers’ molecular Fast Track Diagnostics SARS-CoV-2 Assay, which has 100% specificity and sensitivity. The new assay uses real-time polymerase chain reaction (PCR) to detect ribonucleic acid (RNA) from this virus. The company plans to ship more than 1.3 million tests per month worldwide…

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By: Judy Mathias
April 30, 2020
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OSHA issues guidance on reuse, decontamination of N95 respirators

Editor's Note The Occupational Safety and Health Administration (OSHA) on April 24 issued interim guidance on the reuse and decontamination of N95 and other filtering-facepiece respirators during the COVID-19 pandemic. OSHA notes that the National Institute for Occupational Safety and Health (NIOSH) has identified research that suggests the following methods…

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By: Judy Mathias
April 29, 2020
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Joint Commission supports CDC’s recommendations on universal masking of staff, patients, visitors

Editor's Note The Joint Commission on April 23 announced that it supports the Centers for Disease Control and Prevention’s new recommendations that healthcare facilities “. . . implement source control for everyone entering a healthcare facility (eg, healthcare personnel, patients, visitors), regardless of symptoms . . .” Source control involves…

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By: Judy Mathias
April 23, 2020
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CMS issues recommendations on reopening hospitals in areas with low COVID-19 incidence

Editor's Note: The Centers for Medicare & Medicaid Services (CMS) on April 19 issued recommendations on how hospitals and healthcare systems can protect their staff and patients as they reopen for nonemergent care. The new recommendations update earlier guidance on limiting nonessential surgical and medical procedures and are specifically targeted…

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By: Judy Mathias
April 20, 2020
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CDC: Characteristics of healthcare workers with COVID-10

Editor's Note The Centers for Disease Control and Prevention (CDC) on April 14 released a Morbidity and Mortality Weekly Report on the characteristics of healthcare workers (HCW) with COVID-19 in the US. From February 12 to April 9, 2020, there were 9,282 cases of COVID-19 reported among HCWs. The median…

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By: Judy Mathias
April 16, 2020
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FDA updates actions taken in response to COVID-19

Editor's Note Among the actions announced April 15 by the Food & Drug Administration (FDA) in response to the COVID-19 pandemic are: Issuance of two new emergency use authorizations (EUAs) for serology tests, to detect for presence of coronavirus antibodies, to Ortho-Clinical Diagnostics, Inc, and Chembio Diagnostic systems, Inc. Issuance…

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By: Judy Mathias
April 16, 2020
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FDA encourages recovered COVID-19 patients to donate plasma for development of therapies

Editor's Note The Food & Drug Administration (FDA) on April 16 provided an update on a potential treatment for COVID-19, called convalescent plasma, and encouraged those who have recovered from the coronavirus to donate this antibody-rich plasma to help others fight this disease. Patients who have fully recovered for at…

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By: Judy Mathias
April 16, 2020
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Safe Flight Instrument Corporation creates ventilator splitter

Editor's Note Safe Flight Instrument Corporation (White Plains, New York), a company that develops aircraft safety and performance technology, has developed the Quad/Vent Splitter that allows four patients to use one ventilator simultaneously, the April 13 Aviation International News Online reports. Using 3-D printing, the device has four independent ports…

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By: Judy Mathias
April 14, 2020
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Joint Commission offers guidance, resources for creating capacity for COVID-19 surge patients

Editor's Note The Joint Commission, in its April 8 online newsletter, announced the creation of a web portal with resources to assist healthcare workers create capacity for surge patients with COVID-19. Included are: Use of Ambulatory Surgery Centers (ASC) as Alternative Care Sites for Hospitals Emergency Management Healthcare Environment Checklist…

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By: Judy Mathias
April 9, 2020
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FDA issues COVID-19 update

Editor's Note The Food & Drug Administration (FDA) on April 7 issued an update on actions the agency has taken in its ongoing response to the COVID-19 pandemic. The actions include: a guidance for remote ophthalmic assessment and monitoring devices to facilitate patient care while reducing patient and healthcare provider…

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By: Judy Mathias
April 8, 2020
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